Hospira Plum 360 Infusion Pump Software Recall for Battery Alarm Defect
Hospira is recalling 62,847 Plum 360 Infusion Pumps with software version 15.02 due to a defect that causes therapy to stop and incorrect alarms to display.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a risk-of-harm product (infusion pump) where therapy interruption and incorrect alarms are possible, but no injuries or illnesses are reported in the source text.
Plain-English summary
Hospira Inc., A Pfizer Company, is recalling 62,847 units of the Plum 360 Infusion Pump, Software Version 15.02. The recall affects pumps distributed nationwide and in 21 other countries, including Australia, Canada, and the United Kingdom. The affected units are identified by List number 30010 and specific serial numbers distributed prior to January 16, 2017.
The recall is due to a software defect where a "Depleted Battery" alarm may display instead of "Replace Battery." On battery power, this defect causes ongoing therapy to stop, alarms to sound, and the pump to shut down after 3 minutes. On AC power, the pump reboots, taking approximately 25 seconds, after which therapy can resume. Additionally, an AC power interruption of 3-7 seconds may trigger an incorrect E323 alarm, stop ongoing therapy, and cause a pump reboot.
Healthcare facilities and users should check their pump software versions and serial numbers against the recall list. If a pump is affected, users should contact Hospira for instructions on how to resolve the issue. The defect poses a risk of therapy interruption and incorrect alarm indications.
The recalled product
- Product
- Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
- Manufacturer
- Hospira Inc., A Pfizer Company
- Category
- Medical Device — Infusion Pump
- Affected units
- 62,847
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- List number 30010
- all products with software version 15.02 distributed prior to January 16
- 2017. Serial numbers 19985403
- 19985406
- 19985408
- 19985428
- 19985439
- 19985440
- 19985450
- 19985464
- 19985878
- 19985879
- 19985880
- 19985881
- 19985882
- 19985883
- 19985884
- 19985885
- 19985886
- 19985887
Distribution
Distributed nationwide across the United States.
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